GB 9706.227-2021 Active

This part of GB 9706 specifies the general requirements for the basic safety and basic performance of ME devices and ME systems.
This part applies to medical electrical equipment and medical electrical systems (hereinafter referred to as ME devices and ME systems).
If a chapter or clause explicitly states that it only applies to ME devices or ME systems, the title and the text of the chapter or clause will indicate this. If this is not the case, the relevant chapter or clause applies to both ME devices and ME systems.
Except for 7.2.13 and 8.4.1, the hazards (sources) caused by the intended physiological effects of ME devices or ME systems within the scope of this part are not specifically required in this part.
This document specifies the basic safety and basic performance of electrocardiogram (ECG) monitoring equipment (hereinafter referred to as ME devices).
This document applies to ME devices used in hospital environments and also outside hospital environments (for example, ambulances and air transport). This document also applies to ECG telemetry systems used in hospital environments.
ME devices intended for use in extreme environmental conditions or uncontrolled environments outside hospital environments (for example, ambulances and air transport) should meet the requirements of this document. ME devices used in the above-mentioned environments may also need to comply with other standards.
This document does not apply to dynamic ("Holter") monitors, fetal heart rate monitors, pulse recorders, and other ECG recording devices. This document does not apply to home ECG monitors. However, if their intended use applies to the relevant chapters in this document, manufacturers should take this into account.